Endovascular system with circumferentially-overlapping stent-grafts

• US 8,951,298 B2
• Filed: 06/19/2012
• Issued: 02/10/2015
• Est. Priority Date: 06/21/2011
• Status: Active Grant

• Current Assignee: Japan Lifeline Co., Ltd.
• Original Assignee: Endospan Ltd.
• Inventors: Shalev, Alon
• Primary Examiner(s): Erezo, Darwin
• Assistant Examiner(s): Kapoor, Sidharth
• Application Number:
  US13/807,906
• Publication Number:
  US 20130204343A1
• Time in Patent Office: 966 Days
• Field of Search: 623/1.11, 623/1.16, 623/1.35, 623/1.23, 623/1.36, 623/1.21, 623/1.3
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/852 Two or more distinct overlapping stents
• CPC Class Codes: A61F 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• CPC Class Codes: A61F 2/962 having an outer sleeve
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/8486 provided on at least one of the ends
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2250/0063 Nested prosthetic parts

Abstract

A multi-component endovascular stent-graft system (10) includes a body portion (16), which includes a plurality of stent-grafts (20), which include: (a) respective stent members (22), which are shaped, when the stent-grafts (20) are in respective radially-expanded states, so as to define respective tubes, each of which is circumferentially complete at at least one longitudinal location therealong; and (b) respective graft members (24), which circumscribe respective circumferential arcs (40) of the respective stent members (22). The circumferential arcs (40) have respective extents that are less than entire circumferences of the respective stent members (22) at least partially along respective axial lengths of the stent members (22).

Claims

1. Apparatus comprising a multi-component endovascular stent-graft system, which has proximal and distal ends, and a body portion disposed along at least a part of the stent-graft system longitudinally between the proximal and distal ends, which body portion has an axial length and comprises a plurality of stent-grafts, which (a) are configured to assume respective radially-compressed states for transluminal delivery, and respective radially-expanded states for intraluminal fixation, and (b) comprise:

respective stent members, which are shaped, when the stent-grafts are in their respective radially-expanded states, so as to define respective tubes, each of which is circumferentially-complete at least one longitudinal location therealong; and

respective graft members, which respectively comprise one or more biologically-compatible substantially blood-impervious flexible sheets, and which are securely fixed to the stent members, respectively, such that the graft members circumscribe respective circumferential arcs of the respective stent members, which circumferential arcs have respective extents that are less than entire circumferences of the respective stent members at least partially along respective axial lengths of the stent members, when the stent-grafts are in their respective radially-expanded states

wherein the graft members collectively cover an entire circumference of the body portion and define a circumferentially-closed volume along the entire axial length of the body portion, when (a) the stent-grafts are nested within one another along the entire axial length of the body portion, with predefined rotational and axial relationships therebetween, and (b) the stent-grafts are in their respective radially-expanded states.

2. The apparatus according to claim 1, wherein the graft members are securely fixed to the stent members, respectively, such that the circumferential arc extents are less than the entire circumferences of the respective stent members along at least 80% of the respective axial lengths of the stent members, when the stent-grafts are in their radially-expanded states.

3. The apparatus according to claim 2, wherein the graft members are securely fixed to the stent members, respectively, such that the circumferential arc extents are less than the entire circumferences of the respective stent members along the entire respective axial lengths of the stent members, when the stent-grafts are in their radially-expanded states.

4. The apparatus according to claim 1, wherein at least one of the respective arc extents is between 1.1π

(pi) and 1.4π

(pi) radians.

5. The apparatus according to claim 1, wherein at least one of the respective arc extents is between 0.75π

(pi) and 1.1π

(pi) radians.

6. The apparatus according to claim 1, wherein at least one of the respective arc extents is between 0.6π

(pi) and 0.75π

(pi) radians.

7. The apparatus according to claim 1, wherein pairs of circumferentially-adjacent graft members have respective circumferential overlaps having respective arc extents, each of which is at least 0.05π

(pi) radians, when (a) the stent-grafts are nested within one another along the entire axial length of the body portion, with the predefined rotational and axial relationships therebetween, and (b) the stent-grafts are in their respective radially-expanded states.

8. The apparatus according to claim 7, wherein each of the overlaps is at least 0.1π

(pi) radians.

9. The apparatus according to claim 7, wherein a sum of the respective arc extents is greater than 2.2π

(pi) radians, when (a) the stent-grafts are nested within one another along the entire axial length of the body portion, with the predefined rotational and axial relationships therebetween, and (b) the stent-grafts are in their respective radially-expanded states.

10. The apparatus according to claim 9, wherein the sum is equal to at least 2.6π

(pi) radians.

11. The apparatus according to claim 9, wherein the sum is equal at least (a) 2π

(pi) plus (b) a product of (i) a number of the stent-grafts and (ii) 0.1π

(pi) radians.

12. The apparatus according to claim 1, wherein the circumferential arcs have respective arc angular centers, which are positioned at respective circumferential locations that vary along at least a portion of the axial length of the body portion, when (a) the stent-grafts are nested within one another along the entire axial length of the body portion, with the predefined rotational and axial relationships therebetween, and (b) the stent-grafts are in their respective radially-expanded states.

13. The apparatus according to claim 1, wherein the stent-graft system is shaped so as to define a side-facing fenestration, when (a) the stent-grafts are nested within one another along the entire axial length of the body portion, with the predefined rotational and axial relationships therebetween, and (b) the stent-grafts are in their respective radially-expanded states.

14. The apparatus according to claim 12, wherein the respective circumferential locations vary along the entire axial length of the body portion when (a) the stent-grafts are nested within one another along the entire axial length of the body portion, with the predefined rotational and axial relationships therebetween, and (b) the stent-grafts are in their respective radially-expanded states.

15. The apparatus according to claim 12, wherein the respective arc extents are generally constant along the entire axial length of the body portion, when (a) the stent-grafts are nested within one another along the entire axial length of the body portion, with the predefined rotational and axial relationships therebetween, and (b) the stent-grafts are in their respective radially-expanded states.

16. The apparatus according to claim 13, wherein the side-facing fenestration is generally circular.

17. The apparatus according to claim 16, wherein a perimeter of the fenestration is between 10% and 50% of a perimeter of the stent-graft system adjacent the fenestration.

24. The apparatus according to claim 1, wherein the circumferential arcs have respective arc angular centers, which are positioned at respective substantially constant circumferential locations along the entire axial length of the body portion, when (a) the stent-grafts are nested within one another along the entire axial length of the body portion, with the predefined rotational and axial relationships therebetween, and (b) the stent-grafts are in their respective radially-expanded states.

25. The apparatus according to claim 1, wherein the respective arc extents vary along the entire axial length of the body portion, when (a) the stent-grafts are nested within one another along the entire axial length of the body portion, with the predefined rotational and axial relationships therebetween, and (b) the stent-grafts are in their respective radially-expanded states.

26. The apparatus according to claim 1, wherein the body portion is disposed along only part of the stent-graft system.

27. The apparatus according to claim 1, wherein the stent-graft system further comprises a plurality of outwardly protruding fixation elements.

28. The apparatus according to claim 1, wherein each of the tubes respectively defined by the stent members is circumferentially-complete along at least three longitudinal locations thereof.

29. The apparatus according to claim 1, further comprising a plurality of delivery catheters, in which the stent-grafts are respectively initially positioned in their radially-compressed states.

30. The method according to claim 16, wherein providing the stent-graft system comprises providing the stent-graft system in which the graft members are securely fixed to the stent members, respectively, such that the circumferential arc extents are less than the entire circumferences of the respective stent members along at least 80% of the respective axial lengths of the stent members, when the stent-grafts are in their radially-expanded states.

31. The method according to claim 30, wherein providing the stent-graft system comprises providing the stent-graft system in which the graft members are securely fixed to the stent members, respectively, such that the circumferential arc extents are less than the entire circumferences of the respective stent members along the entire respective axial lengths of the stent members, when the stent-grafts are in their radially-expanded states.

18. A method comprising:

(i) providing a multi-component endovascular stent-graft system, which has proximal and distal ends, and a body portion disposed along at least a part of the stent-graft system longitudinally between the proximal and distal ends, which body portion has an axial length and comprises a plurality of stent-grafts, which (a) are configured to assume respective radially-compressed states for transluminal delivery, and respective radially-expanded states for intraluminal fixation, and (b) include (x) respective stent members, which are shaped, when the stent-grafts are in their respective radially-expanded states, so as to define respective tubes, each of which is circumferentially-complete at least one longitudinal location therealong, and (y) respective graft members, which respectively comprise one or more biologically-compatible substantially blood-impervious flexible sheets, and which are securely fixed to the stent members, respectively, such that the graft members circumscribe respective circumferential arcs of the respective stent members, which circumferential arcs have respective extents that are less than entire circumferences of the respective stent members at least partially along respective axial lengths of the stent members, when the stent-grafts are in their respective radially-expanded states;

(ii) transvascularly introducing a first one of the stent-grafts into a blood vessel of a human subject, while the stent-graft is restrained in its radially-compressed state;

(iii) thereafter, deploying the first stent-graft in the blood vessel so that the first stent-graft assumes its radially-expanded state;

(iv) thereafter, introducing another one of the stent-grafts into the blood vessel and at least partially into the first stent-graft and any of the other stent-grafts already deployed, while the another stent-graft is restrained in its radially-compressed state;

(v) thereafter, axially and rotationally orienting the another stent-graft with the first stent-graft and any of the other stent-grafts already deployed, and deploying the another stent-graft in the blood vessel so that the another stent-graft assumes its radially-expanded state; and

(vi) thereafter, repeating steps (iv) and (v) until all of the stent-grafts have been deployed in the blood vessel

wherein deploying the stent-grafts comprises deploying the stent-grafts such that the graft members collectively cover an entire circumference of the body portion and define a circumferentially-closed volume along the entire axial length of the body portion.

19. The method according to claim 18, wherein deploying the stent-grafts comprises deploying the stent-grafts such that pairs of circumferentially-adjacent graft members have respective circumferential overlaps having respective arc extents, each of which is at least 0.05π

(pi) radians.

20. The method according to claim 19, wherein each of the overlaps is at least 0.1π

(pi) radians.

21. The method according to claim 18, wherein providing the stent-graft system comprises providing the stent-graft system in which each of the tubes respectively defined by the stent members is circumferentially-complete along at least three longitudinal locations thereof.

22. The method according to claim 18, wherein the blood vessel is an aorta, and wherein deploying the stent-grafts comprises deploying the stent-grafts in the aorta.

23. The method according to claim 22, further comprising identifying the subject as suffering from an aortic aneurysm, and wherein deploying the stent-grafts comprises deploying the stent-grafts responsively to the identifying.